Sleep Timing and Energy Balance

Sleep Clinical Trial

Official title:

Effect of Sleep Timing, Independent of Duration, on Food Intake and Metabolic Control of Energy Balance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01866280
• Other study ID #: ST-01
• Status: Completed
• Phase: N/A
• First received: April 24, 2013
• Last updated: April 17, 2015
• Start date: November 2012
• Est. completion date: September 2013

Study information

• Verified date: April 2015
• Source: St. Luke's-Roosevelt Hospital Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test the effects of sleep and meal timing, independent of sleep duration, on glucose regulation and metabolic and hormonal control of energy balance in normal weight adults.

This study will be a 4-phase, randomized controlled study of 5 days each in which participants will undergo 2 phases of late sleep times that differ in meal timing (normal or late) and 2 phases of normal sleep times that differ in meal timing (normal or late).

The Aims and Hypotheses of this study are:

Aim 1: To compare hormonal regulation of food intake and metabolic risk markers in response to altered sleep and meal timing.

• Hypothesis 1: There will be an interaction between sleep and meal time on glucose, insulin, and glucose and insulin area under the curve after the glucose tolerance test such that the late sleep/late meal will result in the worst metabolic profile, normal sleep/late meal and late sleep/normal meal will have an intermediate profile, and normal sleep/normal meal will result in the best metabolic profile.

• Hypothesis 2: There will be an interaction between sleep and meal time on leptin and ghrelin concentrations such that the late sleep/late meal timing phase will result in low leptin/high ghrelin, normal sleep/late meal timing and late sleep/normal meal will have an intermediate profile, and normal sleep/normal meal timing will result in high leptin/low ghrelin.

Aim 2: To compare food intake over a 24-h period in response to altered sleep and meal timing.

• Hypothesis 3: Energy and fat intakes will be greater during the late sleep timing phase compared to normal sleep timing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Body mass index 22-25

• Normal scores on sleep questionnaires (PSQI, ESS, Berlin, SDIQ)

• Normal score on Beck Depression Inventory

• Intermediate chronotype on Composite Scale of Morningness/Eveningness

Exclusion Criteria:

• Neurological, medical, or psychiatric disorders

• Eating disorders

• Diabetes

• Sleep disorders

• Travel across time zones

• History of drug/alcohol abuse

• Caffeine intake >300 mg/d

• Excessive daytime sleepiness

• Pregnancy or within 1 y post-partum

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Meals
• Sleep

Intervention

Behavioral:
• Normal sleep
Normal sleep= sleep 2300-0700
• Normal meals
Normal meal times=approximately 1.5, 5, and 11 h after wake up for breakfast, lunch, and dinner, and snack at 13 h after wake up time
• Late sleep
Late sleep=sleep at 0230-1030 hours
• Late meals
Late meal times= approximately 4.5, 7, and 13 h after wake up time for breakfast, lunch and dinner, and snack at 15 h.

Locations

Country	Name	City	State
United States	St. Luke's/Roosevelt Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
St. Luke's-Roosevelt Hospital Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Food intake	Ad libitum food intake will be assessed on day 5	Single day	No
Primary	Oral Glucose Tolerance	Oral glucose tolerance test will be performed at scheduled breakfast time on day 4	2 hours	Yes
Primary	Meal tolerance test	Glucose and insulin responses to a liquid meal will be assessed at scheduled lunch time	3 hours	No
Secondary	Hormonal profile	On day 3, the following hormones will be assessed from overnight hours: glucose, insulin, cortisol, melatonin, leptin, ghrelin, PYY, GLP-1	24 hours	No